Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 17, 2014
BD Insyte Autoguard Catheter An active safety engineered peripheral IV catheter with a retracting needle to reduce accidental needle stick injuries. The safety feature (needle retraction) of this device is activated when the clinician depresses the button located on the superior surface of the grip. This product is used to provide access to the intravascular system for administration of fluids, medication, blood and blood products and for the withdrawal of the blood samples.
BD Insyte Autoguard may have potential damage along the body of the catheter.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Becton Dickinson & Company recalled BD Insyte Autoguard Catheter An active safety engineered peripheral IV catheter with a… - a moderate-severity action.
BD Insyte Autoguard Catheter An active safety engineered peripheral IV catheter with a… was recalled by Becton Dickinson & Company in December 17, 2014. Reason: BD Insyte Autoguard may have potential damage along the body of the catheter.. Check the official notice for the remedy. Verify recall #Z-0572-2015 with the FDA Devices before acting.
The recall
Becton Dickinson & Company issued this moderate-severity FDA Devices recall-BD Insyte Autoguard may have potential damage along the body of the catheter..
- Moderate
- severity level
- Class II
- classification
- December 17, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0572-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0572-2015) was formally reported on December 17, 2014, with the manufacturer initiating the action on October 9, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Becton Dickinson & Company is listed as the recalling firm, operating out of Franklin Lakes, NJ. Federal records list the affected scope as US- 296,800 devices; OUS - 3,250,150 devices.
The documented reason for this recall is: BD Insyte Autoguard may have potential damage along the body of the catheter. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (naitonwide) and Internationally to South Africa, Spain, Italy, Canada, Japan, Panama, Costa Rica, Mexico, Peru, and Timor Leste.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
US- 296,800 devices; OUS - 3,250,150 devices
Related Recalls
6
3 from same agency
Product description
BD Insyte Autoguard Catheter An active safety engineered peripheral IV catheter with a retracting needle to reduce accidental needle stick injuries. The safety feature (needle retraction) of this device is activated when the clinician depresses the button located on the superior surface of the grip. This product is used to provide access to the intravascular system for administration of fluids, medication, blood and blood products and for the withdrawal of the blood samples.
Reason for recall
BD Insyte Autoguard may have potential damage along the body of the catheter.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0572-2015 |
| Date reported | December 17, 2014 |
| Date initiated | October 9, 2014 |
| Recalling firm | Becton Dickinson & Company |
| Firm location | Franklin Lakes, NJ |
| Affected scope | US- 296,800 devices; OUS - 3,250,150 devices |
| Distribution | Worldwide Distribution - USA (naitonwide) and Internationally to South Africa, Spain, Italy, Canada, Japan, Panama, Costa Rica, Mexico, Peru, and Timor Leste. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0572-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
BD Insyte Autoguard Catheter An active safety engineered peripheral IV catheter with a retracting needle to reduce accidental needle stick injuries. The safety feature (needle retraction) of this device is activated when the clinician depresses the button located on the superior surface of the grip. This product is used to provide access to the intravascular system for administration of fluids, medication, blood and blood products and for the withdrawal of the blood samples.. Recalled by Becton Dickinson & Company. Units affected: US- 296,800 devices; OUS - 3,250,150 devices.
Why was this product recalled? ▼
BD Insyte Autoguard may have potential damage along the body of the catheter.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 17, 2014. Severity: Moderate. Recall number: Z-0572-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (naitonwide) and Internationally to South Africa, Spain, Italy, Canada, Japan, Panama, Costa Rica, Mexico, Peru, and Timor Leste..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0572-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 17, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.